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U.S. Department of Health and Human Services

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Enforcement Report for March 2, 2005

The FDA Enforcement Report is published weekly by the Food and Drug Administration, Department of Health and Human Services. It contains information on actions taken in connection with agency Regulatory activities.

March 2, 2005
05-09

RECALLS AND FIELD CORRECTIONS: FOODS - CLASS I

_______________________________
PRODUCT
ACME' Sliced Smoked Nova Salmon, NET WT. 8 OZ. (227 g). --- INGREDIENTS: SMOKED SALMON (SALMON, SALT, SUGAR, NATURAL HARDWOODSMOKE, SODIUM NITRITE). The product is packaged in a plastic tub container with a plastic lid. Barcode # 0 23384 10105 7. Recall # F-193-5.
CODE
SELL BY 122404.
RECALLING FIRM/MANUFACTURER
Acme Smoked Fish Corp, Brooklyn, NY, by press release and letter, dated 12/30/04. Firm initiated recall is complete.
REASON
The product was found to be contaminated with Listeria monocytogenes, a pathogenic organism, based on sampling & analysis by the New York State Department of Agriculture & Markets.
VOLUME OF PRODUCT IN COMMERCE
204 , 8 oz. units.
DISTRIBUTION
NY.

 RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS II

_______________________________
PRODUCT
Ultra Flu and Ultra Cap, Nasal Decongestant, Cough Suppressant, Antihistamine, (500 mg acetaminophen, 15 mg dextromethorphan HBr, 2 mg chlorpheniramine maleate) Pain Reliever, Fever Reducer, 25 tablets per bottle, NDC #11383-227-25 and NDC #11383-226-25. Recall # D-133-5.
CODE
Lot #4293, Exp. 9/05.
RECALLING FIRM/MANUFACTURER
Weeks & Leo, Co., Inc., Urbandale, IA, by letter dated December 31, 2004 and by letter and telephone on January 14, 2005. Firm initiated recall is ongoing.
REASON
Labeling: Label lacks the declaration of pseudoephedrine HCI 30 mg.
VOLUME OF PRODUCT IN COMMERCE
2,342/25-tablet bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: DRUGS - CLASS III

______________________________
PRODUCT
a) Pramosone cream 1% (hydrocortisone acetate 1%
and pramoxine HCl 1%) packaged in 3 gram
professional sample size metal tubes; Rx only,
NDC 0496-0716-33. Recall # D-134-5;
b) Pramosone cream, 2.5% (hydrocortisone acetate
2.5% and pramoxine HCl 1%), packaged in 3 gram
professional sample size metal tubes; Rx only,
NDC 0496-0717-33. Recall # D-135-5.
CODE
a) Lot 03083B, Exp. 04/05;
b) Lot 030909A, Exp. 04/05;
Lot 03229A, Exp. 10/05 and
Lot 04047A, Exp. 03/06.
RECALLING FIRM/MANUFACTURER
Ferndale Laboratories, Inc., Ferndale, MI, by letters mailed between February 4, 2005 and February 8, 2005. Firm initiated recall is ongoing.
REASON
Defective container: The metal tubes may have pinhole defects, which would result in a super potent product.
VOLUME OF PRODUCT IN COMMERCE
561,260 tubes.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Imodium Advanced Caplets (Loperamide HCl 2 mg
/Simethicone 125 mg). The product is packaged in a
p ouch containing 2 caplets. Recall # D-136-5;
b) Imodium Advanced Caplets (Loperamide HCl 2
mg/Simethicone 125 mg), The product is packaged in
bottles containing 42 caplets. Recall # D-137-5.
CODE
a) Lot #HPC025, exp. 10/31/05;
b) Lot #JHF082, exp. 6/30/06.
RECALLING FIRM/MANUFACTURER
McNeil Consumer & Specialty Pharmaceuticals, Division of McNeil PPC, Inc., Fort Washington, PA, by telephone on December 17, 2004, and by letter on February 7, 2005. Firm initiated recall is ongoing.
REASON
Dissolution Failure.
VOLUME OF PRODUCT IN COMMERCE
258,750 pouches and 36,888 bottles.
DISTRIBUTION
Nationwide.

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS II

_______________________________
PRODUCT
Human Tissue for Transplantation. Recall # B-0533-5.
CODE
2004-12-6107, 2004-12-6108.
RECALLING FIRM/MANUFACTURER
Heartland Lions Eye Bank, Kansas City, MO, by telephone on January 4, 2005, and by certified letter dated January 6, 2005. Firm initiated recall is complete.
REASON
Human tissue for transplantation, procured from a donor who tested negative for antibody to hepatitis C virus (anti-HCV), but was subsequently found to have tested positive for the hepatitis C virus by PCR testing, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 Corneas.
DISTRIBUTION
Kansas City, MO.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0545-5.
CODE
Unit 0375106.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane, WA, by facsimile on July 21, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to previous blood product administration, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
Austria.

_______________________________
PRODUCT
Platelets, Leukocytes Reduced. Recall # B-0546-5.
CODE
Unit C62135, R34834.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, S. Bend, IN, by telephone and by letter dated December 9, 2004. Firm initiated recall is complete.
REASON
Platelets, lacking quality control testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0548-5.
CODE
Units C61920, C61921, H12672, H12708, R34645, R34648, R34650, R34663.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, S. Bend, IN, by telephone on October 4, 2004. Firm initiated recall is complete.
REASON
Red Cells, lacking proper pre-transfusion testing, were distributed.
VOLUME OF PRODUCT IN COMMERCE
8 units.
DISTRIBUTION
IN.

_______________________________
PRODUCT
Red Blood Cells Leukocytes Reduced. Recall # B-0603-5.
CODE
Unit 11GE23823.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by telephone on April 23 and 24, 2004, and by electronic mail or letter dated May 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MO.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0605-5;
b) Recovered Plasma. Recall # B-0606-5.
CODE
a) and b) Unit number: 71M478630.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Center, Marion Region, Ocala, FL, by facsimile on July 30, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for Hepatitis B surface antigen (HBsAg) and for the antibody to Hepatitis B core antigen (anti-HBc), but were collected from a donor who had close contact with an individual who had positive test results for hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
AL and Switzerland.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0639-5;
b) Fresh Frozen Plasma. Recall # B-0640-5;
c) Platelets Pheresis Leukocytes Reduced.
Recall # B-0641-5;
d) Platelets Pheresis Leukocytes Reduced
Irradiated. Recall # B-0642-5.
CODE
a) and b) Unit K56345;
c) and d) Unit V02446.
RECALLING FIRM/MANUFACTURER
Virginia Blood Service, Inc., Richmond, VA, by letters dated September 13 and l7, 2004. Firm initiated recall is complete.
REASON
Blood products, which were collected from donors in which donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
4 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0644-5;
b) Platelets. Recall # B-0645-5.
CODE
a) and b) Unit number K15328.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on July 22, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from an unsuitable donor based on travel to an area considered endemic for malaria, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelets. Recall # B-0648-5.
CODE
Unit number N55636.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on January 9, 2003. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0649-5.
CODE
Unit number K84812.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on March 16, 2004. Firm initiated recall is complete.
REASON
Blood product collected from an unsuitable donor due to a possible history of residing in an area considered at increased risk of exposure to variant Creutzfeldt-Jakob Disease (vCJD).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelets. Recall # B-0650-5.
CODE
Unit number K81141.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on March 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0651-5.
CODE
Unit number K71628.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on February 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor that did not answer one of the medical history questions concerning behavior known to increase risk of infection with the human immunodeficiency virus (HIV), was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
GA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0655-5.
CODE
F-00894-117, F-01572-117.
RECALLING FIRM/MANUFACTURER
DCI Biologicals, Lubbock, TX, by facsimile on November 6, 2002. Firm initiated recall is complete.
REASON
Blood product, collected from a donor who was at increased risk for new variant Creutzfeldt-Jakob Disease (vCJD), were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
NC.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0656-5.
CODE
Unit numbers: 030GX65848, 030GX65853.
RECALLING FIRM/MANUFACTURER
American Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on October 7, 2004, and by letter, dated October 12, 2004. Firm initiated recall is complete.
REASON
Blood products, collected using a hematocrit centrifuge that did not have quality control properly performed, was distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0657-5.
CODE
Units G07736117, G36449117, G36757117, G37230117, G41136117, G44868117, G45055117, G45847117, G48358117, G48762117, G50928117, and G51169117.
RECALLING FIRM/MANUFACTURER
DCI Biologicals, LLC, Lubbock, TX, California, Spain, the United Kingdom, and Switzerland by facsimile on September 25, 2001. Firm initiated recall is complete.
REASON
Blood products, which were collected from a donor who was incarcerated and who engaged in high risk behavior, were distributed.
VOLUME OF PRODUCT IN COMMERCE
12 units.
DISTRIBUTION
CA, Spain, the United Kingdom, and Switzerland.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0658-5.
CODE
Unit V06870.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated September 17, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0659-5.
CODE
Unit number: 2703289.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on June 21, 2004, and by letter, dated June 23, 2004. Firm initiated recall is complete.
REASON
Blood product, which tested initially reactive for an infectious disease on an invalidated test run but subsequently tested negative on a single repeat run, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
KY.

_______________________________
PRODUCT
Red Blood Cells, Deglycerolized, Leukocytes Reduced, Irradiated. Recall # B-0662-5.
CODE
Unit number: 0911625.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by telephone on July 9, 2004, and by letter, dated July 12, 2004. Firm initiated recall is complete.
REASON
Blood product, which was not adequately examined for residual glycerol, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0664-5;
b) Fresh Frozen Plasma. Recall # B-0665-5;
c) Recovered Plasma. Recall # B-0666-5.
CODE
a) Unit numbers N72280, N49965, and M31196;
b) Unit number N49965;
c) Unit numbers N72280 and M31196.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on January 9, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from an ineligible donor due to behavior known to increase risk of infection with human immunodeficiency virus (HIV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
6 units.
DISTRIBUTION
TN, and NY.

_______________________________
PRODUCT
Platelets. Recall # B-0667-5.
CODE
Unit number K59305.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on December 3, 2003. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Plavix, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0668-5.
CODE
Unit number 2153484.
RECALLING FIRM/MANUFACTURER
Blood Bank of Delaware, Inc., aka Blood Bank of Delmarva, Newark, DE, by letter on October 12, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of the medication Avodart, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
MD.

_______________________________
PRODUCT
Source Plasma. Recall # B-0669-5.
CODE
Unit numbers G-92194-195 and G-92765-195.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, San Antonio, TX, by facsimile on May 12, 2003. Firm initiated recall is complete.
REASON
Blood products, that tested negative for antibodies to human immunodeficiency virus, types 1 and 2 (anti-HIV-1/2), but were collected from a donor that subsequently reported a previous reactive test for anti-HIV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced Irradiated. Recall # B-0670-5.
CODE
Unit number 04P55140.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, New England Region, Dedham, MA, by telephone on October 26, 2004, and by letter on October 28, 2004. Firm initiated recall is complete.
REASON
Blood product, collected in a manner that may have compromised the sterility of the unit, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
ME.

_______________________________
PRODUCT
Whole Blood. Recall # B-0671-5.
CODE
Unit number 030LL03613.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Northeastern Pennsylvania Region, Ashley, PA, by telephone on October 6, 2004, and by letter on October 12, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of a medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0674-5.
CODE
Unit number: 33GY87203.
RECALLING FIRM/MANUFACTURER
American Red Cross, Connecticut Region, Farmington, CT, by telephone on November 19, 2004, and by letter, dated November 30, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of Platelets possibly contaminated with Micrococcus sp. and Klebsiella oxytoca, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CT.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0675-5;
b) Fresh Frozen Plasma. Recall # B-0676-5.
CODE
a) and b) Unit number: 3172285.
RECALLING FIRM/MANUFACTURER
Recalling Firm: LifeSource, Glenview, IL, by telephone on October 27 and 28, 2004.
Manufacturing Firm: LifeSource Villa Park, Villa Park, IL. Firm initiated recall is complete.
REASON
Blood products, corresponding to a unit of Platelets possibly contaminated with Staphylococcus aureus, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0677-5.
CODE
Unit numbers: G-70441-021, F-01316-021, F-03028-021, F-03160-021, and F-04222-021
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Oklahoma City, OK, by facsimile on April 24, 2003. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who received a tattoo within twelve months prior to donation, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 Units.
DISTRIBUTION
Spain and NC.

_______________________________
PRODUCT
Platelets. Recall # B-0681-5.
CODE
Unit number: KJ70089.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by telephone on October 2, 2004, and by facsimile, dated December 21, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to Red Blood Cells that were possibly contaminated with Staphylococcus epidermidis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0682-5.
CODE
Unit numbers: 150026381, 150026644, 150027280, 150027598, 150028144, 150028445, 150028950, 150029305, 150029803, 150030080, 150031093, 150031721, 150032040, 150032599, 150032942, 150034196, 150034573, 150035026, 150035482, 150035872, 150036277, 150036648, 150037086, 150037588, 150037985, 150038375, 150039192, 150039742, 150039950, 150040553, 150040761, 150041318, 150044156, 150044957, 150045127, 150045536, 150045713, 150046234, 150046446, 150046966, 150047067, 150047530, 150047653, 150048144, 150048304, 150050153, 150050392, 150050987, 150051199, 150051671, 150051938, 150052367, 150053932, 150054346, 150054821, 150055121, 150055461, 150055815, 150056190, 150056369, 150056915, 150057197, 150057540, 150059531, 150059976, 150060233, 150060578, 150060831, 150061246, 150061442, 150061852, 150062273, 150062516, 150062928, 150063160, 150063459, and 150063702.
CALLING FIRM/MANUFACTURER
Biomat USA, Inc., Kalamazoo, MI, by facsimile on October 19, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor based on a previously reactive test for anti-HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
77 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0683-5.
CODE
Unit number: GV64359.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on July 23, 2004. Firm initiated recall is complete.
REASON
Blood product, corresponding to Platelets that were possibly contaminated with Bacillus subtilis, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0684-5;
b) Cryoprecipitated AHF. Recall # B-0685-5;
c) Plasma. Recall # B-0686-5.
CODE
a), b) and c) Unit V17151.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated September 13, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Source Plasma. Recall # B-0687-5.
CODE
Unit numbers: G-92990-040, G-93602-040,
G-93858-040, G-94370-040, G-94735-040, G-05027-040,
G-05216-040, G-05917-040, G-06697-040, G-09194-040,
G-10141-040, G-10335-040, G-13018-040, G-13177-040,
G-14342-040, G-14912-040, G-15267-040, G-15518-040,
G-16080-040, N-06617-040, N-06651-040, G-32904-040,
G-33117-040, G-33567-040, G-33791-040, and G-35221-040.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Killeen, TX, by facsimile sent December 11, 2002. Firm initiated recall is complete.
REASON
Blood products, collected from a donor who had unexplained needle marks, were distributed.
VOLUME OF PRODUCT IN COMMERCE
26 units.
DISTRIBUTION
CA, NC, and Germany.

_______________________________
PRODUCT
Platelets Pheresis. Recall # B-0689-5.
CODE
Unit number K68744.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on February 2, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an ineligible donor due to use of a medication, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Source Plasma. Recall # B-0691-5.
CODE
Unit numbers 0400014261 and 0400014343.
RECALLING FIRM/MANUFACTURER
Biomat USA, Inc., Wilmington, DE, by facsimile on August 20, 2004. Firm initiated recall is complete.
REASON
Blood products, that tested negative for viral markers, but were collected from a donor that did not have the physical examination performed properly, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
Spain.

_______________________________
PRODUCT
Source Plasma. Recall # B-0692-5.
CODE
Unit number 05462797.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN, by facsimile on October 15, 2004. Firm initiated recall is complete.
REASON
Blood product tested negative for viral markers but was collected from an ineligible donor due to a risk factor for increased incidence of infection with human immunodeficiency virus (HIV).
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0694-5.
CODE
Unit 7753379.
RECALLING FIRM/MANUFACTURER
Suncoast Communities Blood Bank, Inc., Sarasota, FL, by facsimile on June 29, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor based on travel to an area considered endemic for malaria, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0695-5;
b) Recovered Plasma. Recall # B-0696-5.
CODE
a) and b) Unit number: 11FZ46171.
RECALLING FIRM/MANUFACTURER
American Red Cross, Missouri-Illinois Region, St. Louis, MO, by telephone on April 22, 2004 and by letters, dated May 3 and 11, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis, but were collected from an ineligible donor due to a reported history of hepatitis, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
CA and AR.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0697-5.
CODE
Unit 71 L33071-7.
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Lake City, FL, by telephone and e-mail on March 24, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose partner had a confirmed positive test for hepatitis B, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells Pheresis, Irradiated. Recall # B-0698-5.
CODE
Units 71M12444-6 (2 components).
RECALLING FIRM/MANUFACTURER
LifeSouth Community Blood Centers, Inc., Gainesville, FL, by facsimile on June 17, 2004. Firm initiated recall is complete.
REASON
Blood products, for which documentation of irradiation was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
FL.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0700-5.
CODE
Unit K34532.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letter dated September 13, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from an unsuitable donor due to the use of the medications Estrace and Zestril, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Removed, Irradiated. Recall # B-0703-5.
CODE
Unit numbers: 3010989, 3020685, and 3020686.
RECALLING FIRM/MANUFACTURER
Inland Northwest Blood Center, Spokane WA, by telephone on March 10, 2004. Firm initiated recall is complete.
REASON
Blood products, incorrectly tested for Cytomegalovirus (CMV), were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
WA.

_______________________________
PRODUCT
Platelets. Recall # B-0704-5.
CODE
Unit KJ69493.
RECALLING FIRM/MANUFACTURER
Central Blood Bank, Pittsburgh, PA, by facsimile on August 13, 2004. Firm initiated recall is complete.
REASON
Blood product, which was manufactured from a whole blood unit in which the corresponding red blood cell unit contained clots, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
PA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0706-5.
CODE
Unit P11900.
RECALLING FIRM/MANUFACTURER
South Bend Medical Foundation, S. Bend, IN, by telephone and by letter dated December 9, 2004. Firm initiated recall is complete.
REASON
Platelets, with a positive bacterial detection screen, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IN.
 

RECALLS AND FIELD CORRECTIONS: BIOLOGICS - CLASS III

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0451-5.
CODE
Unit 5158651.
RECALLING FIRM/MANUFACTURER
The Blood Center of New Jersey, East Orange, NJ, by telephone on November 20, 2003. Firm initiated recall is complete.
REASON
Blood product, corresponding to a unit of clotted Fresh Frozen Plasma, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
NJ.

_______________________________
PRODUCT
Recovered Plasma. Recall # B-0604-5.
CODE
Unit 11GE23823.
RECALLING FIRM/MANUFACTURER
American Red Cross Blood Services, St. Louis, MO, by telephone on April 23 and 24, 2004, and by electronic mail or letter dated May 13, 2004. Firm initiated recall is complete.
REASON
Blood products, which tested negative for hepatitis B surface antigen (HBsAg), but were collected from a donor who previously tested positive for HBsAg, were distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.

_______________________________
PRODUCT
Red Blood Cells. Recall # B-0637-5.
CODE
Unit V14132.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Inc., Richmond, VA, by electronic mail on September 9, 2004, and by letter dated September 13, 2004. Firm initiated recall is complete.
REASON
Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Platelets Pheresis, Leukocytes Reduced. Recall # B-0638-5.
CODE
Units 2039459.
RECALLING FIRM/MANUFACTURER
Medic Inc., Knoxville, TN, by letter dated April 15, 2004. Firm initiated recall is complete.
REASON
Platelets, collected from a donor who previously tested positive for HCV, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Platelets, Irradiated. Recall # B-0643-5.
CODE
Unit number K17608.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by telephone on June 23, 2003, and by facsimile on December 15, 2003. Firm initiated recall is complete.
REASON
Blood product, untested for human immunodeficiency virus (HIV) and hepatitis C virus (HCV) by the nucleic acid test (NAT) method, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced Irradiated. Recall # B-0646-5.
CODE
Unit numbers K38546 and K43530 (distributed as four split units).
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on October 14, 2003. Firm initiated recall is complete.
REASON
Blood products, that were found to be out of specification for red blood cell recovery, were distributed.
VOLUME OF PRODUCT IN COMMERCE
5 units.
DISTRIBUTION
TN, and AL.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0647-5.
CODE
Unit number L40353.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on October 13, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose arm inspection was not documented, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
TN.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0660-5;
b) Fresh Frozen Plasma. Recall # B-0661-5.
CODE
a) and b) Unit number: 2121397.
RECALLING FIRM/MANUFACTURER
Medic, Inc., Knoxville, TN, by letter dated April 2, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose medical history screening was incomplete, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN.

_______________________________
PRODUCT
AlphaNine SD, Coagulation Factor IX (Human). Recall # B-0663-5.
CODE
Lot CV02003A.
RECALLING FIRM/MANUFACTURER
Alpha Therapeutic Corporation, Los Angeles, CA, by letter dated February 19, 2003. Firm initiated recall is complete.
REASON
Coagulation Factor Concentrate, that failed stability testing at 3 months when stored at 30f C, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 lot.
DISTRIBUTION
AZ, PA, TN, MN, LA, and New England.

_______________________________
PRODUCT
a) Red Blood Cells, Leukocytes Reduced.
Recall # B-0672-5;
b) Platelets. Recall # B-0673-5.
CODE
a) and b) unit number K64537.
RECALLING FIRM/MANUFACTURER
Blood Assurance, Inc., Chattanooga, TN, by facsimile on January 15, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from an ineligible donor due to use of a medication, were distributed.
VOLUME OF PRODUCT IN COMMERCE
2 units.
DISTRIBUTION
TN and GA.

_______________________________
PRODUCT
a) Red Blood Cells. Recall # B-0678-5;
b) Fresh Frozen Plasma. Recall # B-0679-5;
c) Platelets. Recall # B-0680-5.
CODE
a), b), and c) Unit V06698.
RECALLING FIRM/MANUFACTURER
Virginia Blood Services, Richmond, VA, by letters dated September 17, 2004 and October 8, 2004. Firm initiated recall is complete.
REASON
Blood products, collected from a donor whose donor suitability was not adequately determined, were distributed.
VOLUME OF PRODUCT IN COMMERCE
3 units.
DISTRIBUTION
VA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0688-5.
CODE
Unit numbers: 18FQ91014, 18FQ91018, 18FQ91019, 18FQ91020, 18FQ91021, 18FQ91022, 18FQ91023, 18FQ91024, 18FQ91027, 18FQ91028, 18FQ91029, 18FQ91030, 18FQ91031, 18FQ91032, 18FQ91033, 18FQ91034, 18FQ91035, 18FQ91036, 18GQ91037, 18FQ91038, 18FQ91039, 18FQ91040, 18FQ91042, 18FQ91043, 18FQ91044, 18FQ91046, 18FQ91048, 18GF47000, 18GF47001, 18GF47004, 18GF47005, 18GF47006, 18GF47008, 18GF47010, 18GN26801, 18GN26802, 18GN26804, 18GN26807, 18GN26808, 18GN26810, 18GN26812, 18GN26813, 18GN26815, 18GN26816, 18GN26817, 18GN26818, 18GN26819, 18GN26820, 18GN26821, 18GN26822, 18GN26825, 18GN26827, 18GN26828, 18GN26829, 18GN26830, 18GN26831, 18GN26832, 18GN26833, 18GN26834 and 18GN26835.
RECALLING FIRM/MANUFACTURER
American Red Cross, Great Lakes Region, Lansing, MI, by telephone on December 31, 2003, by facsimile on January 2, 2004, and by letter, dated January 7, 2004. Firm initiated recall is complete.
REASON
Blood products, collected without daily quality control being performed, were distributed.
VOLUME OF PRODUCT IN COMMERCE
60 Units.
DISTRIBUTION
MI and PA.

_______________________________
PRODUCT
Red Blood Cells, Leukocytes Reduced. Recall # B-0690-5.
CODE
Unit number 40LV05536.
RECALLING FIRM/MANUFACTURER
The American National Red Cross, Heart of America Region, Peoria, IL, by telephone on November 29, 2004, and by letter on December 7, 2004. Firm initiated recall is complete.
REASON
Blood product, that did not have the complete amount of additive solution included, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
IL.

_______________________________
PRODUCT
Source Plasma. Recall # B-0699-5.
CODE
Unit 77428554.
RECALLING FIRM/MANUFACTURER
Bio-Blood Components, Inc., Hammond, IN, by facsimile on November 19, 2004. Firm initiated recall is complete.
REASON
Blood product, collected from a donor whose eligibility to donate was not adequately verified, was distributed.
VOLUME OF PRODUCT IN COMMERCE
1 unit.
DISTRIBUTION
CA.
 

 RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS II

_______________________________
PRODUCT
Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets. Recall # Z-1014-04.
CODE
Lot P020077.
RECALLING FIRM/MANUFACTURER
Zimmer Spine, Inc., Minneapolis, MN, by letters dated May 25, 2004. Firm initiated recall is ongoing.
REASON
The recalled bone taps could break inside the vertebral body during the tapping process.
VOLUME OF PRODUCT IN COMMERCE
51 units.
DISTRIBUTION
HI, NY, SC, and SD.

_______________________________
PRODUCT
Nichols Advantage 25-Hydroxy Vitamin D Assay, Catalog number 62-7033. Recall # Z-1118-04.
CODE
Not limited to specific lots.
RECALLING FIRM/MANUFACTURER
Nichols Institute Diagnostics, San Clemente, CA, by Customer Bulletin on June 30, 2004. Firm initiated recall is ongoing.
REASON
Lower than expected results are obtained.
VOLUME OF PRODUCT IN COMMERCE
Not specified.
DISTRIBUTION
Nationwide, and Internationally.

_______________________________
PRODUCT
The device generates whole body and head multislice X-ray computed tomography images that are used by the physician in the diagnosis of disease. Brand Name: CT/e; CT/e Dual; CT/e Plus, CT/e Dual Plus; CT/e Lite; ProSpeed AI; ProSpeed AII; ProSpeed FII; ProSpeed EII; CT HiSpeed Series. Recall # Z-0269-05.
CODE
Model or Catalog: 2297024, 2320315, 2244226, 2113694-2, 2115992-4, 2200290-2.
RECALLING FIRM/MANUFACTURER
General Electric Med Systems LLC, Waukesha, WI, by Field Service Engineer visit, beginning on October24, 2004. Firm initiated recall is ongoing.
REASON
Inadequate materials used to manufacture the upper shaft of patient tables that can result in uncontrolled table motion.
VOLUME OF PRODUCT IN COMMERCE
1,150 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
Model Number KXO-80G X-ray High Voltage Generator for Diagnostic Radiology use. Recall # Z-0494-05.
CODE
All codes.
RECALLING FIRM/MANUFACTURER
Toshiba America Medical Systems, Tustin, CA, by Service Representative visit beginning on February 17, 2005. Firm initiated recall is ongoing.
REASON
The units are defective under 21 CFR 1003.2 in that they fail to operate as required by 21 CFR 1020.31(a)(1) - Pre-exposure indication of the technique factors to be used during an exposure. Following an AEC exposure, the selected exposure time is indicated, but subsequent exposures are at the preset back-up time.
VOLUME OF PRODUCT IN COMMERCE
494 units.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
a) Brand Name: EmpowerCT/EmpowerCTA Injector System
Ceiling Column Accessory; Common/Usual Name: CT
Injector System Ceiling Column Accessory, Catalog
Number 9886S. Ceiling Column Accessory: The CT and
CTA Injector Systems employs an Articulating Arm
that mounts to the Ceiling Column Accessory, which
are designated as 9886S (11.25?), M (21.50?), and L
(34.50?), i.e. 9886L. Recall # Z-0548-05;
b) Brand Name: EmpowerCT/EmpowerCTA Injector System
Ceiling Column Accessory; Common/Usual Name: CT
Injector System Ceiling Column Accessory, Catalog
Number 9886M. Ceiling Column Accessory: The CT and
CTA Injector Systems employs an Articulating Arm
that mounts to the Ceiling Column Accessory, which
are designated as 9886S (11.25"), M (21.50"), and L
(34.50"), i.e. 9886L. Recall # Z-0549-05;
c) Brand Name of Device: EmpowerCT/EmpowerCTA Injector
System Ceiling Column Accessory; Common/Usual Name:
CT Injector System Ceiling Column Accessory, Catalog
Number 9886L. Ceiling Column Accessory: The CT and
CTA Injector Systems employs an Articulating Arm
that mounts to the Ceiling Column Accessory, which
are designated as 9886S (11.25"), M (21.50"), and L
(34.50"), i.e. 9886L. Recall # Z-0550-05.
CODE
No lot #s or serial #s assigned to this accessory.
RECALLING FIRM/MANUFACTURER
E-Z-Em Co., Inc., Westbury, NY, by letters dated December 3, 2004. Firm initiated recall is ongoing.
REASON
Out of specification welding could cause the ceiling mount accessory to detach from its mounting. The firm received 1 complaint from a hospital that the injector fell off the ceiling mounting bracket and landed on the floor.
VOLUME OF PRODUCT IN COMMERCE
156 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
RT130 and RT131 Neonatal/Infant Breathing Circuits, heated wire. For use with MR850 Respiratory Humidifier. Recall # Z-0553-05.
CODE
Lot numbers in the range 040701 to 041216.
RECALLING FIRM/MANUFACTURER
Fisher and Paykel Healthcare, Inc., Laguna Hills, CA, by letter on December l7, 2004. Firm initiated recall is ongoing.
REASON
Pressure elbow may be partly occluded.
VOLUME OF PRODUCT IN COMMERCE
2,200.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) LeMaitre Embolectomy Catheter 2F Single Lumen,
Balloon Volume 0.05 ml, Length 60 cm. Latex
Model: 1601-26. Recall # Z-0557-05;
b) LeMaitre Embolectomy Catheter 3F Single Lumen,
Balloon Volume 0.2 ml, Length 80 cm. Latex
Model: 1601-38. Recall # Z-0558-05;
c) LeMaitre Embolectomy Catheter 4F Single Lumen,
Balloon Volume 0.75 ml, Length 80 cm. Latex
Model: 1601-48. Recall # Z-0559-05;
d) LeMaitre Embolectomy Catheter 5F Single Lumen,
Balloon Volume 1.5 ml, Length 80 cm. Latex
Model: 1601-58. Recall # Z-0560-05;
e) LeMaitre Embolectomy Catheter 2F Single Lumen,
Balloon Volume 0.05 ml, Length 80 cm. Latex
Model: 1601-28. Recall # Z-0561-05.
CODE
a) Lot Number: SLC1184;
b) Lot Numbers: SLC1201, SLC1213;
c) Lot Number: SLC1202;
d) Lot Numbers: SLC1193, SLC1209;
e) Lot Number: SLC1205.
RECALLING FIRM/MANUFACTURER
Lemaitre Vascular, Inc., Burlington, MA, by letter on February 7, 2005. Firm initiated recall is ongoing.
REASON
Product sterility maybe compromised due to defective packaging.
VOLUME OF PRODUCT IN COMMERCE
2,228 units.
DISTRIBUTION
AL, CA, FL, IN, MD, MI, NY, TN, and Germany.

_______________________________
PRODUCT
Tissuelink Dissecting Sealer DS3.5-C, Sterile Ref 13-121-1. Recall # Z-0563-05.
CODE
Lot Number: TL033300.
RECALLING FIRM/MANUFACTURER
TissueLink Medical, Inc., Dover, NH, by letter from February 7, 2005 to February 8, 2005. Firm initiated recall is ongoing.
REASON
The tip may separate from the device and render it unusable.
VOLUME OF PRODUCT IN COMMERCE
588 units.
DISTRIBUTION
Nationwide and Internationally.

_______________________________
PRODUCT
a) ZimmerO Orthopaedic Surgical Products, Disposable
Cuff, Dual Port, Double Bladder Cuff. The cuff is
a sterile, single use product equipped with an
integral fill line and packed 10 cuffs per unit.
Cat #60-7080-002-00, Cat #60-7080-003-00, and
Cat #60-7080-002-00. Recall # Z-0564-05;
b) ZimmerO Orthopaedic Surgical Products, Disposable
Cuff, Single Port, Double Bladder Cuff. The cuff is
a sterile, single use product equipped with an
integral fill line and packed 10 cuffs per unit.
Cat #60-7085-003-00, Cat #60-7085-002-00.
Recall # Z-0565-05.
CODE
a) Lot #60135943, Lot #60108064, and
Lot #60162837;
b) Lot #60116761, and Lot #60149051.
RECALLING FIRM/MANUFACTURER
Zimmer Orthopaedic Surgical Products, Statesville, NC, by letter on February 11, 2005. Firm initiated recall is ongoing.
REASON
The port/tube bond in the affected cuffs may separate during surgery causing the pressure in the cuff to release.
VOLUME OF PRODUCT IN COMMERCE
1,890 cuffs.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
Deltec Cozmo 3 ml Insulin Cartridge with 0.7 mm (22G) x 12.5mm (1/2 in.) needle and cap. Reorder #21-1750-24. Made in Mexico. Labeling states Cartridge is Sterile and nonpyrogenic unless package is opened or damaged, Rx Only Recall # Z-0566-05.
CODE
Cartridge Lot Number 005X64 and Cartridge Lot Number 007X64.
RECALLING FIRM/MANUFACTURER
Smiths Medical MD, Inc., Saint Paul, MN, by letter on October 15, 2004. Firm initiated recall is ongoing.
REASON
Complaints relating to two lots of Cozmo Cartridges describing leakage of insulin into the cartridge chamber.
VOLUME OF PRODUCT IN COMMERCE
2,886 boxes (25 insulin cartridges per box).
DISTRIBUTION
Nationwide.
 

RECALLS AND FIELD CORRECTIONS: DEVICES - CLASS III

_______________________________
PRODUCT
Cypher BX Velocity Cardio Sirolimus Eluting Stents. All CWSXXXXX and CRSXXXXX.BX Velocity stent coated with the pharmaceutical agent, Sirolimus. Recall # Z-0555-05.
CODE
Lot # A0904001, A0904022, A0904024, 40904001, 40904013, 50904003, 50904555, X0904001 and X0904999.
RECALLING FIRM/MANUFACTURER
Cordis Corporation, Miami Lakes, FL, by letter in November 2004. Firm initiated recall is ongoing.
REASON
Inventory control stickers had incorrect expiration date. The stickers stated the expiration date was November 2004 instead of October 2004.
VOLUME OF PRODUCT IN COMMERCE
922,994 Stents.
DISTRIBUTION
Nationwide.

_______________________________
PRODUCT
The Triathlon Posteriorly Stabilized Femoral Component. Recall Z-0556-05.
CODE
Catalog Number--Lot Code: 5511-F-301--ER0215;
5511-F-301--PR04139; 5511-F-301--PR04664;
5511-F-301--PR04862; 5511-F-301--PR04891;
5511-F-301--PR04955; 5511-F-301--PR41122;
5511-F-301--PR4352; 5511-F-301--PR4424;
5511-F-301--PR4425; 5511-F-301--PR4427;
5511-F-301--PR4519; 5511-F-301--PR4734;
5511-F-301--PR4736; 5511-F-302--ER0184;
5511-F-302--PR04795; 5511-F-302--PR04808;
5511-F-302--PR04809; 5511-F-302--PR04810;
5511-F-302--PR04840; 5511-F-302--PR04887;
5511-F-302--PR04902; 5511-F-302--PR4113;
5511-F-302--PR41142; 5511-F-302--PR41143;
5511-F-302--PR4256; 5511-F-302--PR42561;
5511-F-302--PR4429; 5511-F-302--PR4430;
5511-F-302--PR4432; 5511-F-302--PR4520;
5511-F-302--PR4727; 5511-F-302--PR4738;
5511-F-302--PR4739; 5511-F-302--PR4774;
5511-F-302--PRO4626; 5511-F-302--PRO4627;
5511-F-302--PRO4629; 5511-F-401--PR04811;
5511-F-401--PR04848; 5511-F-401--PR04849;
5511-F-401--PR04865; 5511-F-401--PR04866;
5511-F-401--PR04867; 5511-F-401--PR04881;
5511-F-401--PR04882; 5511-F-401--PR4107;
5511-F-401--PR41073; 5511-F-401--PR4115;
5511-F-401--PR4435; 5511-F-401--PR4437;
5511-F-401--PR4718; 5511-F-401--PR4740;
5511-F-401--PR4775; 5511-F-401--PR4779;
5511-F-402--ER0219; 5511-F-402--PR04805;
5511-F-402--PR04805; 5511-F-402--PR04806;
5511-F-402--PR04850; 5511-F-402--PR04851;
5511-F-402--PR04880; 5511-F-402--PR04905;
5511-F-402--PR04906; 5511-F-402--PR4116;
5511-F-402--PR4258; 5511-F-402--PR4440;
5511-F-402--PR4442; 5511-F-402--PR4443;
5511-F-402--PR4716; 5511-F-402--PR4728;
5511-F-402--PR4777; 5511-F-501--ER0217;
5511-F-501--ER0250; 5511-F-501--PR4117;
5511-F-501--PR4118; 5511-F-501--PR4254;
5511-F-501--PR42541; 5511-F-501--PR42593;
5511-F-501--PR4418; 5511-F-501--PR4444;
5511-F-501--PR4445; 5511-F-501--PR4446;
5511-F-501--PR4448; 5511-F-501--PR4449;
5511-F-501--PR4450; 5511-F-501--PR4452;
5511-F-501--PR4524; 5511-F-501--PR4767;
5511-F-502--ER0218; 5511-F-502--PR04884;
5511-F-502--PR04885; 5511-F-502--PR05008;
5511-F-502--PR41191; 5511-F-502--PR41194;
5511-F-502--PR4379; 5511-F-502--PR4456;
5511-F-502--PR4457; 5511-F-502--PR4458;
5511-F-502--PR4459; 5511-F-502--PR4460;
5511-F-502--PR4461; 5511-F-502--PR4525;
5511-F-502--PR4526; 5511-F-502--PR4527;
5511-F-502--PR4768; 5511-F-502--PR4778;
5511-F-601--ER0185; 5511-F-601--ER0280;
5511-F-601--PR04886; 5511-F-601--PR04904;
5511-F-601--PR05021; 5511-F-601--PR05052;
5511-F-601--PR05229; 5511-F-601--PR41421;
5511-F-601--PR41422; 5511-F-601--PR41423;
5511-F-601--PR4464; 5511-F-601--PR4528;
5511-F-601--PR4529; 5511-F-601--PR4752;
5511-F-601--PR4753; 5511-F-601--PR4798;
5511-F-601--PR5026; 5511-F-601--PR5032;
5511-F-601--PR5037; 5511-F-601--PR5046;
5511-F-601--PR5108; 5511-F-601--PR5110;
5511-F-602--ER0186; 5511-F-602--ER0253;
5511-F-602--ER0254; 5511-F-602--ER0265;
5511-F-602--J66915; 5511-F-602--PR04662;
5511-F-602--PR04828; 5511-F-602--PR04863;
5511-F-602--PRO4864; 5511-F-602--PR4099;
5511-F-602--PR42731; 5511-F-602--PR4470;
5511-F-602--PR4471; 5511-F-602--PR4472;
5511-F-602--PR4754; 5511-F-602--PR4757;
5511-F-602--PR4772; 5511-F-602--PR4776;
5511-F-602--PR4781; 5511-F-602--PR4901;
5511-F-602--PR5111; 5511-F-602--PR5112.
Several units of the same lot number are reported in the quantity distributed.
RECALLING FIRM/MANUFACTURER
Stryker Howmedica Osteonics, Corp., Mahwah, NJ, by letter on October 27, 2004. Firm initiated recall is ongoing.
REASON
The fatigue testing of the Triathlon PS Femoral Component does not consistently meet the requirements of the finite element analysis predicted load as delineated in the 510(k) submittal.
VOLUME OF PRODUCT IN COMMERCE
386 units.
DISTRIBUTION
Nationwide.

END OF ENFORCEMENT REPORT FOR MARCH 2, 2005

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